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STANDARD OPERATING PROCEDURE Research Administration SOP No: Q021
SOP Title: FDAAA 801, The Final Rule (42 CFR Part 11), and ClinicalTrials.Gov Registration
Details regarding request for “User Log-In from PRS Administrator”, “How to Register an Applicable Clinical Trial”, “Required Registration Update”, “Editing ClinicalTrials.Gov Study Records”, and “Submission of Results” can be found in “Frequently Asked Questions” section, Questions D-E and J-L.
Management of the ClinicalTrials.Gov Mailbox and Trial Registration Compliance
1. In order to ensure trial registration, trial updates throughout the course of the study, and reporting of findings, the PRS Administrator role or designee will manage the mailbox and follow-up with researchers regarding registration, updates, and reporting of findings.
2. As “PRS Account Administrator”, the Director of Research Administration will monitor communications from ClinicalTrials.gov and internal stakeholders on a weekly basis and follow-up accordingly.
3. Appointments with researcher will be set-up to register, update, and report findings for each ACT.
9. FREQUENTLY ASKED QUESTION
See Frequently Asked Question Document
A. WhatisClinicalTrials.Gov?
B. Whyisitimportanttoregistermyclinicaltrial?
C. How to Apply for a Protocol Registration and Results System (PRS)
Account
D. Who Should Apply for a PRS Account?
E. How to Apply and Obtain a PRS Account?
F. How do researchers submit a request for user log-in from PRS
administrator?
SOP No. 24, 07-14-2020, 05-31-2022